BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181956 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07077
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 58MG/DL AND 143MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN A TEN MINUTE TIMEFRAME. THE CUSTOMER REPORTS THAT HE SIDE DOSED THE TEST STRIP. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. THE CUSTOMER IS CURRENTLY USING A NEW VIAL OF STRIPS. HE DID NOT PROVIDE STRIP INFO ON THE STRIPS USED TO OBTAIN THE DISCREPANT RESULTS. THE SUSPECTED PRODUCT IS UNAVAILABLE FOR RETURN; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS -LFR LFR ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR METFORMIN - 10 YRS| BYETTA - 2 MONTHS| GLYBURIDE - 6 YRS